Has Nipro Renal Soultions USA, Corporation had other FDA enforcement actions?

Yes. Argus HQ has recorded 4 total FDA actions tied to Nipro Renal Soultions USA, Corporation: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-09-16; Argus observed and indexed it on 2026-09-23.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

Nipro Renal Soultions USA, Corporation — Class II recall: MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X…

Name: FDA Recall Record — Nipro Renal Soultions USA, Corporation
Creator: Argus HQ
Published: 2026-09-16
License: https://argushq.ai/methodology

Event date: 2026-09-16 00:00:00Z
Observed: 2026-09-23 04:20:24Z
Source ID: Z-3134-2026
Payload hash: 4f620301b11c59e3a38213f9…

Summary

Hemodialysis concentrates contain high endotoxin levels Status: Ongoing.

Entities

Nipro Renal Soultions USA, Corporation

View source record ↗

Frequently asked questions

Has Nipro Renal Soultions USA, Corporation had other FDA enforcement actions?: Yes. Argus HQ has recorded 4 total FDA actions tied to Nipro Renal Soultions USA, Corporation: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-09-16; Argus observed and indexed it on 2026-09-23.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Nipro Renal Soultions USA, Corporation — Class II recall: MedicaLyte Bicarbonate Powder    REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-nipro-renal-soultions-usa-corporation-z-3134-2026

MLA

"Nipro Renal Soultions USA, Corporation — Class II recall: MedicaLyte Bicarbonate Powder    REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-nipro-renal-soultions-usa-corporation-z-3134-2026.

Chicago

Argus HQ Research. "Nipro Renal Soultions USA, Corporation — Class II recall: MedicaLyte Bicarbonate Powder    REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X…." Digital Empire Holdings LLC. Accessed September 23, 2026. https://argushq.ai/events/fda-recall-nipro-renal-soultions-usa-corporation-z-3134-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_nipro_renal_soultions_usa_corporation_z_3134_2026_2026,
  title = {Nipro Renal Soultions USA, Corporation — Class II recall: MedicaLyte Bicarbonate Powder    REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-nipro-renal-soultions-usa-corporation-z-3134-2026},
  note = {Accessed: September 23, 2026}
}

Informational only. Not legal, financial, or medical advice.